Stroke
Conditions
Interventions
True Feedback Group:Equipment and Mode: A non-invasive BCI + hand exoskeleton system (AiHand Expanse-BCI-L1) is used. The exoskeleton is driven by real-time decoding of motor imagery (MI), forming a c
each session is approximately 20 minutes, including 7 minutes of modeling + 13 minutes of training.
Modeling Phase: Patients are guided to perform MI with both the affected and healthy hands accordin
patients seated, wearing EEG caps and exoskeletons of the affected hand
a resting EEG for approximately 1 minute before training as a baseline.
Parallel Routine Rehabilitation: Both groups received routine rehabilitation including guideline-recommended exercise therapy,
Sham Feedback Group:Equipment and setting consistent: Similar to the true feedback group, a non-invasive BCI + hand exoskeleton system (AiHand Expanse-BCI-L1) was used in a quiet training room. Partic
Sponsors
First Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects were diagnosed 1 to 6 months after their first ischemic stroke; 2. Subjects experienced their first radiographically confirmed unilateral ischemic stroke within the past 30–180 days; 3. Subjects passed the BCI blind screening; 4. Active wrist extension >10°, thumb adduction/abduction >10°, and extension of at least two other fingers >10°; 5. Fugl-Meyer Assessment - Upper Extremity (FMA-UE) score of 54 or lower (out of 66), with stable upper limb function to avoid the upper limit effect; 6. Modified Rankin Scale (mRS) score <=3; 7. Subjects aged 18–80 years; 8. Informed consent was obtained from the subject or their family.
Exclusion criteria
Exclusion criteria: 1. Primary intracerebral hematoma, subarachnoid hemorrhage, or ischemic stroke affecting both hemispheres or both brainstem regions. 2. Use of medications that may interfere with EEG during the study period, including but not limited to diphenhydramine, methylphenidate, caffeine, chlorpromazine, amitriptyline, and dextromethorphan. 3. Other coexisting neuromuscular diseases affecting upper limb motor function. 4. Other neurological disorders affecting the participant's ability to participate in the study. 5. Moderate to severe cognitive impairment, defined as a Montreal Cognitive Assessment (MOCA) score <18/30. 6. Uncontrolled depression or other neuropsychiatric disorders that were previously treated with medication before or after the stroke. 7. Uncontrolled hypertension, defined as SBP =185 mmHg or DBP =110 mmHg. 8. Any... MRI/EEG risk factors, including but not limited to: electrically, magnetically, or mechanically activated metallic or non-metallic implants, including pacemakers or intracranial vascular clips; non-fixated metallic parts of the body, including previous metal injuries to the eyes; pregnancy; history of epilepsy or post-stroke seizures; scalp lesions at the intended electrode placement site, or bone defects or hemicraniectomy; 9. Receiving botulinum toxin injections in the affected upper limb within the past 3 months; 10. Participating in another stroke recovery study concurrently; 11. Participants are expected to be unable to adhere to study procedures and follow-up; 12. Life expectancy of less than 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Upper Limb Motor Function Measured by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Hand Muscle Strength;Active Range of Motion (ROM) of the Hand and Wrist;Stroke Impact Scale (SIS);EEG-Based Neural Activity Patterns;TMS-Induced Motor Evoked Potentials; | — |
Countries
China
Contacts
Public ContactFanfu Fang
First Affiliated Hospital of Naval Medical University
Outcome results
None listed